(b)Specifications. Disodium EDTA-copper shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:

Total copper, not less than 13.5 percent.

Total (ethylene-dinitrilo) tetracetic acid, not less than 62.5 percent.

Free copper, not more than 100 parts per million.

Free disodium salt of (ethylene-dinitrilo) tetraacetic acid, not more than 1.0 percent.

Moisture, not more than 15 percent.

Water insoluble matter, not more than 0.2 percent.

Lead (as Pb), not more than 20 parts per million.

Arsenic (as As), not more than 3 parts per million.

(c)Uses and restrictions. Disodium EDTA-copper may be safely used in amounts consistent with good manufacturing practices in the coloring of shampoos which are cosmetics.

(d)Labeling requirements. The labeling of the color additive shall conform to the requirements of § 70.25 of this chapter.

(e)Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the requirements of section 721(c) of the act.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Sensient Colors, LLC, proposing that the color additive regulations be amended to provide for the safe use of an aqueous extract of butterfly pea flower ( Clitoria ternatea ) as a color additive in various food categories, at levels consistent with good manufacturing practice.

This rule is effective December 4, 2018. See section X for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing on the final rule by December 3, 2018.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of synthetic iron oxides as color additives to include use in dietary supplement tablets and capsules. This action is in response to a color additive petition (CAP) filed by Colorcon, Inc.

This rule is effective December 3, 2018. See section XIII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing on the final rule by November 30, 2018.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is amending the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp because new data available since lead acetate was permanently listed demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive. This action is in response to a color additive petition filed by the Environmental Defense Fund, Earthjustice, Environmental Working Group, Center for Environmental Health, Healthy Homes Collaborative, Health Justice Project of Loyola University Chicago School of Law, Breast Cancer Fund, Improving Kids' Environment, Consumers Union, Natural Resources Defense Council, Consumer Federation of America, Learning Disabilities Association, Maricel Maffini, and Howard Mielke.

Submit either electronic or written comments on the petitioner's environmental assessment by May 9, 2018.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA, the Agency, or we) is announcing that we have filed a petition, submitted by Aker BioMarine, proposing that the color additive regulations be amended to provide for the safe use of Antarctic krill meal which is composed of the ground and dried tissue of Euphausia superba, for use in the feed of salmonid fish. The use would enhance the color of the salmonid fish flesh.

Submit either electronic or written comments on the petitioner's environmental assessment by April 6, 2018.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA, the Agency, or we) is announcing that we have filed a petition, submitted by GW Cosmetics GmbH, proposing that the color additive regulations be amended to provide for the safe use of silver nitrate in professional-use only cosmetics to color eyebrows and eyelashes.

Effective date of final rule published in the Federal Register of November 7, 2017 (82 FR 51554) confirmed: December 8, 2017.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is confirming the effective date of December 8, 2017, for the final rule that appeared in the Federal Register of November 7, 2017, and that amended the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and in inks used on the surface of chewing gum.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive regulations be amended by expanding the permitted uses of synthetic iron oxide as a color additive to include use in dietary supplement tablets and capsules.

This rule is effective December 8, 2017. See section X for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing on the final rule by December 7, 2017. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of December 7, 2017.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum. We are taking this action in response to a color additive petition submitted by the Wm. Wrigley Jr. Company.

Effective date of final rule published in the Federal Register of July 3, 2017 (82 FR 30731), confirmed: August 3, 2017.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is confirming the effective date of August 3, 2017, for the final rule that appeared in the Federal Register of July 3, 2017, and that amended the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hard-boiled shell eggs at levels consistent with good manufacturing practice.

This rule is effective August 3, 2017. Submit either electronic or written objections and requests for a hearing on the final rule by August 2, 2017. See section IX for further information on the filing of objections.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hard-boiled shell eggs at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) filed by McCormick & Company, Inc. (McCormick).

The color additive petition was filed on February 24, 2017. Submit either electronic or written comments by June 5, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 5, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of June 5, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Environmental Defense Fund, Earthjustice, Environmental Working Group, Center for Environmental Health, Healthy Homes Collaborative, Health Justice Project of Loyola University Chicago School of Law, Breast Cancer Fund, Improving Kids' Environment, Consumers Union, Natural Resources Defense Council, Consumer Federation of America, Learning Disabilities Association, Maricel Maffini, and Howard Mielke, proposing that FDA repeal the color additive regulation providing for the use of lead acetate in cosmetics intended for coloring hair on the scalp.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by DSM Biomedical, proposing that the color additive regulations be amended to provide for the safe use of high purity carbon black for coloring ultra-high molecular weight polyethylene sutures for use in general surgery.

FDA is reopening the comment period for the proposed rule published December 14, 2016 (81 FR 90267). Submit either electronic or written comments by May 1, 2017.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is reopening the comment period for the notice entitled “Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry” that appeared in the Federal Register of December 14, 2016. The draft guidance, when finalized, will help manufacturers determine whether a color additive derived from a plant material meets the specifications under certain FDA color additive regulations. We are taking this action in response to requests to allow interested persons additional time to submit comments.

Effective date of final rule published in the Federal Register of November 1, 2016 (81 FR 75689), confirmed: December 2, 2016.

21 CFR Parts 73 and 74

Summary

The Food and Drug Administration (FDA or we) is confirming the effective date of December 2, 2016, for the final rule that appeared in the Federal Register of November 1, 2016, and that amended the color additive regulations to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper to color orientation marks for intraocular lenses (IOLs). We are taking this action to ensure clarity that the effective date in the final rule remains December 2, 2016.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 13, 2017.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Fruit Juice and Vegetable Juice as Color Additives in Food.” The draft guidance, when finalized, will help manufacturers determine whether a color additive derived from a plant material meets the specifications under certain FDA color additive regulations.

This rule is effective December 2, 2016. See section IX for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by December 1, 2016.

21 CFR Parts 73 and 74

Summary

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper to color orientation marks for intraocular lenses. This action is in response to a petition filed by Milton W. Chu, M.D.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Wm. Wrigley Jr. Company, proposing that the color additive regulations be amended to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by McCormick & Company, Inc., proposing that the color additive regulations be amended to provide for the safe use of spirulina extract to color shell eggs at levels consistent with good manufacturing practice.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Milton W. Chu, M.D., proposing that the color additive regulations be amended to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper as orientation marks for intraocular lenses.

The Food and Drug Administration (FDA or we) is amending certain regulations to update the location of references cited in our food regulations. We are taking this action to reflect the transfer of those references from our facility in College Park, MD, to our library at our main campus in Silver Spring, MD. We also are updating certain regulations to reflect the current names for specific FDA offices.

Effective date of final rule published in the Federal Register of September 30, 2015 (80 FR 58600), confirmed: November 2, 2015.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is confirming the effective date of November 2, 2015, for the final rule that appeared in the Federal Register of September 30, 2015, and that amended the color additive regulations to provide for the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as a color additive in certain distilled spirits.

Effective date of final rule published in the Federal Register of August 21, 2015 (80 FR 50762), confirmed: September 22, 2015.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is confirming the effective date of September 22, 2015, for the final rule that appeared in the Federal Register of August 21, 2015, and that amended the color additive regulations to expand the permitted use of spirulina extract as a color additive to include use in coating formulations applied to dietary supplement and drug tablets and capsules.

This rule is effective November 2, 2015. See section VIII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by October 30, 2015.

21 CFR Part 73

Summary

The Food and Drug Administration (“FDA” or “we”) is amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in certain distilled spirits. This action is in response to a color additive petition (CAP) submitted by E. & J. Gallo Winery.

This rule is effective September 22, 2015. See section IX for information on the filing of objections. Submit either electronic or written objections and requests for a hearing by September 21, 2015.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules. This action is in response to a petition filed by Colorcon, Inc. (Colorcon).

Effective date of final rule published in the Federal Register of June 8, 2015 (80 FR 32303), confirmed: July 9, 2015.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is confirming the effective date of July 9, 2015, for the final rule that appeared in the Federal Register of June 8, 2015, and that amended the color additive regulations to expand the permitted uses of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, cocktails, non-alcoholic cocktail mixers and mixes, and in egg decorating kits for coloring shell eggs.

This rule is effective July 9, 2015. See section VIII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by July 8, 2015.

21 CFR Part 73

Summary

The Food and Drug Administration (“FDA” or “we”) is amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, cocktails, non-alcoholic cocktail mixers and mixes, and in egg decorating kits for coloring shell eggs. This action is in response to two color additive petitions (CAPs) submitted separately by EMD Millipore Corp. and by Signature Brands, LLC.

Effective date of final rule published in the Federal Register of March 20, 2015 (80 FR 14839) confirmed: April 21, 2015.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is confirming the effective date of April 21, 2015, for the final rule that appeared in the Federal Register of March 20, 2015, and that amended the color additive regulations to expand the permitted uses of synthetic iron oxide as a color additive to include use in soft and hard candy, mints, and chewing gum.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by E. & J. Gallo Winery, proposing that the color additive regulations be amended to provide for the safe use of mica-based pearlescent pigments as color additives in certain distilled spirits.

This rule is effective April 21, 2015. See section X for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by April 20, 2015.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of synthetic iron oxide as a color additive to include use in soft and hard candy, mints, and chewing gum. This action is in response to a petition filed by Wm. Wrigley Jr. Company (Wrigley).

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Signature Brands, LLC, proposing that the color additive regulations be amended to provide for the safe use of mica-based pearlescent pigments in egg decorating kits for coloring shell eggs.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive regulations be amended to provide for the safe use of spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by EMD Millipore Corp., proposing that the color additive regulations be amended to expand the safe use of mica-based pearlescent pigments in alcoholic beverages to include cordials, liqueurs, cocktails, and certain other alcoholic beverages, and non-alcoholic mixers and mixes.

The effective date for the final rule published April 11, 2014 (79 FR 20095), is confirmed as May 13, 2014.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is confirming the effective date of May 13, 2014, for the final rule that appeared in the Federal Register of April 11, 2014, and that amended the color additive regulations to expand the permitted use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis ( A. platensis ) as a color additive in food.

This rule is effective May 13, 2014. See section X for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by May 12, 2014.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of spirulina extract as a color additive in food. This action is in response to a petition filed by GNT USA, Inc.

The effective date for the final rule published August 13, 2013 (78 FR 49117), is confirmed as September 13, 2013.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is confirming the effective date of September 13, 2013, for the final rule that appeared in the Federal Register of August 13, 2013. The final rule amended the color additive regulations to provide for the safe use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis ( A. platensis ), as a color additive in candy and chewing gum.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Wm. Wrigley Jr. Company, proposing that the color additive regulations be amended to expand the use of synthetic iron oxide to include soft and hard candy, mints, and chewing gum. The petition also proposes to lower the specification limit for lead in synthetic iron oxide for human food use.

The Food and Drug Administration (FDA or we) is confirming the effective date of July 15, 2013, for the final rule that appeared in the Federal Register of June 12, 2013 (78 FR 35115). The final rule amended the color additive regulations to provide for the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in distilled spirits containing not less than 18 percent and not more than 23 percent alcohol by volume but not including distilled spirits mixtures containing more than 5 percent wine on a proof gallon basis.

This rule is effective September 13, 2013. See section X for related information on the filing of objections. Submit either electronic or written objections and requests for a hearing by September 12, 2013.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis ( A. platensis ), as a color additive in candy and chewing gum. This action is in response to a petition filed by Mars, Inc.

The Food and Drug Administration (FDA or we) is confirming the effective date of May 2, 2013, for the final rule that published in the Federal Register of April 1, 2013 (78 FR 19413), and that amended the color additive regulations to provide for the safe use of additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) and copolymers of 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) as color additives in contact lenses.

This rule is effective July 15, 2013. See section VIII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by July 12, 2013.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in distilled spirits containing not less than 18 percent and not more than 23 percent alcohol by volume but not including distilled spirits mixtures containing more than 5 percent wine on a proof gallon basis. This action is in response to a petition filed by E. & J. Gallo Winery.

This rule is effective May 2, 2013. See section VII for related information on the filing of objections. Submit either electronic or written objections and requests for a hearing by May 1, 2013.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) and copolymers of 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) as color additives in contact lenses. This action is in response to two color additive petitions (CAPs) filed by CooperVision, Inc.

The Food and Drug Administration (FDA) is amending certain regulations regarding food and color additives to correct minor errors (such as misspelled chemical names) and to update office names and addresses. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a color additive petition (CAP 4C0276) proposing that the color additive regulations be amended to provide for the safe use of synthetic iron oxide as a color additive in or on cooked meat products.

The Food and Drug Administration (FDA) is announcing that GNT USA, Inc. (GNT) has filed a petition proposing that the color additive regulations be amended to provide for the safe use of spirulina concentrate, made from the edible blue-green cyanobacterium Arthrospira platensis (also known as Spirulina platensis ) as a color additive in food.

The Food and Drug Administration (FDA) is announcing that E. & J. Gallo Winery has filed a petition proposing that the color additive regulations be amended to provide for the expanded safe use of mica-based pearlescent pigments as color additives in certain distilled spirits.

The Food and Drug Administration (FDA) is announcing that Mars, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of spirulina blue, an extract made from the biomass of Anthrospira platensis (spirulina), to color candy and chewing gum.